Home / 510(k) Clearances / K970750

510(k) K970750

MICROSPAN INSEMINATION SYSTEM by Imagyn Medical, Inc. — Product Code MFD

K970750 is an FDA 510(k) premarket notification submitted by Imagyn Medical, Inc. for the device "MICROSPAN INSEMINATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 5, 1997. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Imagyn Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1997
Date Received
March 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Intrauterine Insemination
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type

Other clearances by Imagyn Medical, Inc.

  • K972426 — MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH (September 23, 1997)
  • K971255 — IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER (April 21, 1997)
  • K965055 — IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES (March 6, 1997)
  • K963580 — IMAGYN FALLOPOSCOPY SYSTEM (January 31, 1997)
  • K961688 — MICROSPAN HYSTEROSCOPE (October 15, 1996)
  • K961506 — MICROSPAN HYSTEROSCOPE SHEATH (July 3, 1996)
  • K952032 — IMAGYN HYSTEROSCOPE SHEATHS (October 31, 1995)
  • K951996 — IMAGYN ENDOSCOPE (September 1, 1995)
  • K951974 — IMAGYN ENDOSCOPE SHEATH (August 28, 1995)
  • K953201 — IMAGYN UROSCOPE (August 2, 1995)

Other clearances for product code MFD

  • K021438 — INSEMINATION CATHETER, MODEL 320301 (July 16, 2002)
  • K012935 — THECURVE, ITEM 507 (October 11, 2001)
  • K984306 — `THE INSEMINATOR' (PROPOSED) (March 1, 1999)
  • K982630 — MEDWORKS VISUALIZATION INSEMINATION CATHETER (January 14, 1999)
  • K982628 — MEDWORKS INSEMINATION CATHETER (August 21, 1998)
  • K980061 — EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATIO (March 2, 1998)
  • K972823 — MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER (October 10, 1997)
  • K972245 — TOM CAT F.L., TOM CAT S.L. (August 6, 1997)
  • K964848 — WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM (January 16, 1997)
  • K963031 — GENXCATHETER (October 21, 1996)

FDA data resources